Each tube is provided with a cylindrical disc 31.4 ± 0.13 mm in diameter and 15.3 ± 0.15 mm thick, made of transparent plastic with a relative density of 1.18–1.20. Each disc is pierced by
7 holes
Each tube is provided with a cylindrical disc 31.4 ± 0.13 mm in diameter and 15.3 ± 0.15 mm thick, made of transparent plastic with a relative density of 1.18–1.20. Each disc is pierced by 7 holes, each (blank) in diameter
3.15 ± 0.1 mm
in the center
1
1 in the center and the other 6 spaced equally on a circle of radius
4.2 mm
The tubes are held vertically by 2 separate and superimposed rigid plastic plates
97 mm in diameter and 9 mm thick with 3 holes.
Method for test B
Test 6 tablets or capsules either by using (blank) assemblies in parallel or by repeating the procedure
2 basket-rack
In each of the 3 tubes place 1 tablet or capsule and, if prescribed, add a disc; suspend the assembly in the beaker containing the specified
liquid
Operate the apparatus using water as the immersion fluid unless another liquid is specified for the prescribed period, withdraw the assembly and examine the state of the
tablets or capsules.
To pass the test all (blank) of the tablets or capsules must have disintegrated
6
Disintegration Media 1. Temperature must be maintained a
37 degrees centigrade
Disintegration Media
a. Distilled water b. Simulated Gastric fluid TS c. Simulated Intestinal fluid TS
Specifications:
All tablets should disintegrate completely
Uncoated Tablets Medium
Water/ buffer
Film-Coated Tablets
water
Sugar coated Tablets
Water/ 0.1N HCl
Dispersible Tablets
water
Effervescent Tablets
water
Enteric-coated Tablets
0.1M HCl+ phosphate buffer pH 6.8
Soluble Tablets
water
Temp. 37°±2 °C
Uncoated Tablet, Film-Coated Tablets, Sugar-coated Tablets, Enteric-coated Tablets